A Telemedicine Prenatal Care Model on Low Risk Pregnants: The m@Mae-e Study — m@mae-e  

COVID-19 Pandemic Clinical Trial

Official title: A Telemedicine Prenatal Care Model on Low Risk Pregnants: An Effectiveness Randomized Clinical Trial (The m@Mae-e Study)

Status Not yet recruiting

Clinical Trial Summary

This study will compare the effectiveness of a prenatal care supported by telemedicine against usual care in low-risk pregnant women. The investigators will follow-up women in a gestational age of 6 weeks up to 41 weeks, and 6 postpartum weeks. The primary outcome is the anxiety level estimated by the General Anxiety Scale 7 scale (GAD-7 Scale).

Clinical Trial Description

This is a pragmatic, effectiveness, superiority randomized clinical trial (RCT), in which low risk pregnants will be randomized to a prenatal care program supported by telemedicine or usual care in an allocation ratio of 1:1. The follow-up period will last 41 weeks from inception (i.e., 6 to 13 weeks of gestational age) to pregnancy and a extension period of 6 weeks in the postpartum stage. The investigators settled anxiety levels estimated by the General Anxiety Scale 7 scale as primary outcome in a between-groups mean difference after the 3rd trimester. Secondary outcomes include: delivery mode, obstetric events and fetal and neonatal variables of epidemiological surveillance interest (birth weight, birth height and APGAR score; maternal, fetal and neonatal fatal and non-fatal events). The interventions will occur as follows: for usual care, all appointments (at least 9 outpatient clinic visits) will be carried forward in person by a senior obstetrician. Patients randomized for the telemedicine supported group should will attend at least 6 in person and 3 online appointments. All pregnant women will receive the standardized care throughout the study. The sample size calculation was based on the primary outcome, assuming between-groups mean difference of 4 points plus a 4-points standard deviation, at a statistical of 80% and a two-tailed 5% type I error. Further, a 15% of addition was done for potential impairments during the follow-up, ending in 30 patients per group. The m@mae-e study's setting will be the at Santa Casa de Misericórdia, (Porto Alegre, Brazil). ;

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Mental Disorders
• Prenatal Stress

• NCT number: NCT05745896
• Study type: Interventional
• Source: Federal University of Health Science of Porto Alegre
• Contact: Talita Colombo, MD, MSc
• Phone: +55 51 3024 5657
• Email: talitacolombo@ufcspa.edu.br
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Completion date: March 1, 2026